User-retainable temperature and impedance monitoring methods and devices

ABSTRACT

A user-retainable monitoring system is disclosed. At least a pair of sensors is provided in association with a support member. The support member is preferably of a type that may be worn by or at least temporarily implanted in a patient. Possible sensor types include temperature sensors and impedance sensors. Temperature sensors may be used to detect a temperature differential between areas of tissue indicative of pathology. Impedance sensors are used to detect subcutaneous fluid detection. The support member may take the form of a bandage, drain or other structure. Monitor structures as described may have stand-alone utility or be connected to a processor or data recorder to enable various functions.

FIELD OF THE INVENTION

The present invention relates to tissue monitoring, especially withapparatus suited for sustained or continued use by patients. Certainapplications address concerns with wound healing including infection andsubcutaneous fluid build-up, another addresses inflammation as intransplant rejection.

BACKGROUND OF THE INVENTION

Fluid accumulation and infection at the site of a wound cansignificantly hinder wound healing. Fluid accumulation can exert adetrimental mass effect upon adjacent tissue and compress vital anatomyor structures. Infection can result in tissue morbidity, rejection,fever, gangrene and even death.

Background discussion regarding fluid accumulation and tissue infectionfollows, in turn. That certain information is presented as backgroundherein should not, however, be taken as indication that the presentinvention does not predate it.

With respect to fluid accumulation, if detected before significantdamage occurs, it can often be treated by simple surgical intervention.For instance, lancing and/or drain insertion or implantation may provideadequate and continuing therapeutic relief.

Impedance measurement has been employed to measure volumetric changes ofthe body in certain applications. U.S. Pat. No. 4,805,621 to Heinze etal. discloses a system adapted to measure body tissue impedance,particularly to set the rate of a pacemaker by reference to volumetricmeasurement of a beating heart and thorax during respiration movement.Heinze neither discloses or suggests the use of local impedancedifferences to locate or monitor indicia negative of proper woundhealing.

Regarding infection, it is well established that infection can beeffectively treated by antibiotics. Also, antibiotics can be effectivelyadministered prophylactically to avoid infection. However, this approachmay not be desired for reasons ranging from drug interaction, tobacterial resistance to antibiotics. Regardless, it is desired and oftennecessary to repeatedly check, examine or monitor an area forinfection—especially prior to administering antibiotics.

It is also known that infected tissue presents at a higher temperaturerelative to uninfected tissue. U.S. Pat. No. 6,135,968 to Brounsteinteaches the use of temperature sensors affixed to an insulative supportto fit over or be adhered to a probe (such as a finger) for accessinginternal body locations via body orifices to effect temperature-basedexaminations. The preferred embodiments include two discrete temperaturesensing regions allowing for comparative analysis of tissue temperature.As stated in the patent, an important function of the temperature sensorsupport in all embodiments of the invention is to insulate a temperaturesensing patch from the fingertip of the user and thereby improve theaccuracy of the sensed temperatures by isolating temperature sensed bythe sensing patch from the influence of heat emanating from the user'sfingertip. Closed cell polyurethane foam with a thickness of about 1 to2 millimeters is disclosed as a suitably pliable and insulative materialfor the temperature sensor support.

By comparing the temperature of near-by healthy tissue with that of asuspect site, a diagnosis can be made as to the existence of abnormalsubsurface tissue activity such as the growth of malignant tumors,benign neoplasms, infections and/or inflammations. The devices involvedand examination techniques disclosed are, however, by no means suitedfor long-term infection monitoring.

One recently disclosed device is, however, suited for sustainedmonitoring of wounds for infection. In a Nov. 5, 2001 issue of MedicalIndustry Today, a story was run reporting that the University ofRochester had taken steps toward creating a bandage that will changecolor depending on what kind of bacteria may be present in a wound. Thebandage was disclosed as capable of giving an instant diagnosis as towhether the wound may require special care or what kind of antibioticswould work best in treating it. A silicon-based sensor is employed todifferentiate between Gram-positive and negative bacteria. Indication offurther application include similar sensors to identify several othertypes of bacteria, with particular focus on research directed towardantibiotic resistant strains. As embodied in a “smart bandage,” thesensor is said to function in connection with a type of molecule called“lipid A” on the surface of Gram-negative bacteria. When a complementarymolecule linked to or part of the sensor binds to lipid A, the sensorchanges color.

The article indicates that color change of the sensor is subtle andcould be missed by a human eye. Accordingly, reading by an ancillarydevice is discussed. One embodiment envisioned for the bandage includesan array of dozens of different bacterial sensors that will change colordramatically enough so a glance inspection will alert the user to aserious infection.

Potential non-medical applications are also disclosed in which, forexample, a drinking vessel or wrapping around a package of ground beefwould change color to caution a user in the event of the presence ofcertain bacteria. Further potential applications envisioned includeproviding early warning against biowarfare.

The breakthrough described in association with the development of thebandage was detecting and identifying a single, distinct species ofbacteria. Further development possibilities were linked in the articleto finding molecules that detect other bacteria. In any case, thesilicon sensors only have bacteria-specific wound monitoring capability.Furthermore, even if the prophesized sensor arrays come into being, theywill only detect such forms of bacteria corresponding specifically tothe array elements. Accordingly the smart bandage approach taught in thearticle lacks general applicability. To remedy this, the article merelysuggests searching for molecules capable of detecting other bacteria toadd functionality in a piecemeal fashion.

SUMMARY OF THE INVENTION

The present invention is geared toward broad-based detection of woundand/or implant-related complications. Sensors registering localtemperature differences give indication of infection. Temperaturesensing aspects of the invention also find use in monitoring otherconditions such the progression to completeness of normal wound healing,the state of anesthetized tissue, local immune responses tovaccinations, the flow of blood to muscle flaps or other tissues and themargins of viability of tissues affected by bums or frostbite. Impedancesensing provides indication of fluid build up or the volumetric statusat a site. Such methodology may be used in monitoring for post-surgicalhematomas, and proper functioning of devices such as shunts, grafts anddrains.

In serving each such use, the present invention integrates sensorsformats that are amenable to prolonged retention by a patient. Holdingthe sensors in close anatomic association with a subject or patient foran extended period through the use of an easily-retainable supportallows for constant or periodic monitoring by a patient, physician orother care provider.

User retainable formats include support structures suited for externalas well as internal use. In addition to those described herein, furtheruses, advantages and features distinguishing the present invention mayalso be apparent to those with skill. The various apparatus as well asassociated methodology described herein form aspects of the presentinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

Each of the following figures provides examples diagrammaticallyillustrating aspects of the present invention. Like elements in thevarious figures are indicated by identical numbering. For the sake ofclarity, some such numbering has been omitted.

FIGS. 1A-1D show views of various sensor types as may be used in thepresent invention.

FIGS. 2A-2J show views of various support member types as may be used inthe present invention.

FIGS. 3-6 show monitors according to the present invention in use.

DETAILED DESCRIPTION

In describing the invention in greater detail than done above, thesubject monitoring system and underlying technology are addressed first,followed by examples of apparatus produced according to the presentinvention and associated methodology. Before the present invention isdescribed in such detail, however, it is to be understood that thisinvention is not limited to particular variations set forth and may, ofcourse, vary. Various changes may be made to the invention described andequivalents may be substituted without departing from the true spiritand scope of the invention. In addition, many modifications may be madeto adapt a particular situation, material, composition of matter,process, process step or steps, to the objective, spirit and scope ofthe present invention. All such modifications are intended to be withinthe scope of the claims made herein. Furthermore, where a range ofvalues is provided, it is understood that every intervening value,between the upper and lower limit of that range and any other stated orintervening value in that stated range is encompassed within theinvention. The upper and lower limits of these smaller ranges mayindependently be included in the smaller ranges and is also encompassedwithin the invention, subject to any specifically excluded limit in thestated range. Where the stated range includes one or both of the limits,ranges excluding either both of those included limits are also includedin the invention. Also, it is contemplated that any optional feature ofthe inventive variations described herein may be set forth and claimedindependently, or in combination with any one or more of the featuresdescribed herein.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, the preferredmethods and materials are described. All existing subject mattermentioned herein (e.g., writings, publications, patents, patentapplications and hardware) is incorporated by reference herein in itsentirety. The referenced items are provided solely for their disclosureprior to the filing date of the present application. Nothing herein isto be construed as an admission that the present invention is notentitled to antedate such material by virtue of prior invention.

Also, it is noted that as used herein and in the appended claims, thesingular forms “a”, “and,” “said” and “the” include plural referentsunless the context clearly dictates otherwise. Conversely, it iscontemplated that the claims may be so-drafted to require singularelements or exclude any optional element indicated to be so here in thetext or drawings. This statement is intended to serve as antecedentbasis for use of such exclusive terminology as “solely,” “only” and thelike in connection with the recitation of claim elements or the use of a“negative” claim limitation(s).

Variations of the present invention include temperature and/or impedancesensors provided in connection with a support element or member. Thepresent invention takes forms that the a patient may wear (e.g., abandage, strip, pad or patch, sleeve, bracelet, suction cup(s) or wrap)or retains internally (e.g., a shunt, catheter, drain or prosthesis),possibly by implantation. The form-factor employed determines whethermonitoring is accomplished at or near the surface of the patient's skinor within the patient's body. Both the format of the apparatus andassociated sensors may be configured to monitor for infection, near-byfluid accumulation or other indica. Continued use by a patient for(several) minutes, on the order of hours, days, weeks or longer iscontemplated with the present invention. Use for an extended period oftime is contemplated. Sometimes, a monitor according to the presentinvention will be worn or retained by a patient for up to 60 days orlonger (as in the case of permanent or semi-perminent implants).

Before describing the various forms the invention may take, togetherwith applications they are suited for, optional sensor types are firstdescribed. As shown in FIG. 1A, an impedance sensor 2 is provided usingsimple electrical leads 4. A proximal end 6 of each such sensor memberis typically connected to a diagnostic instrument. Exemplaryinstruments, or components thereof, such as described in U.S. Pat. No.4,805,621 to Heinze et al.; U.S. Pat. No. 4,837,501 or U.S. Pat. No.5,068,618, each to Fry et al. or other circuitry able to measure bodytissue impedance may be used in connection with these sensor members.

In operation, AC current or voltage is applied through the leads via apre-defined spectrum of frequencies or selected single frequencies asneeded. For impedance sensor variations of the invention, there willalways be at least two electrodes, since one needs a source and sink forcurrent (in this case, alternating current).

Changes of the impedance of tissue to current flow varies as a functionof the state of the tissue. The attenuation of current flow throughtissues is a function of the biological properties of the same as wellas the frequency of the current. Normal and pathological statesdemonstrate different impedance profiles. The presence of or changes inthese profile(s) correlate with different physiological states.Additionally, the penetration of AC currents is frequency dependent. So,for a given case, such as searching for hematomas post-surgically, anappropriate selection of frequencies should yield the ability to “look”deeper or shallower in the tissue.

Whether provided as described in the above-reference patent(s) orotherwise, a current or voltage generating means is coupled to thesensor members for use. In addition, voltage or current detecting meansmay be coupled thereto, or a specially adapted impedance sensing meansmay be utilized in connection with the impedance sensor members.

A distal end 10 of each lead or probe may directly contact body tissueor it may be in electrical contact with the body via pads, caps oranother intermediate interface member. The same is true for the othersensors disclosed herein. Some part may be placed in direct contact witha user or an intermediate layer of material or member may be present.Especially in connection with temperature sensors, any such structurepreferably enjoys a high thermal conductivity or is at least so thinthat it interferes little with patient temperature sensor readings.

FIG. 1B shows a first type of temperature sensor that may be used. Athermocouple 12 is shown. A thermocouple is provided by a junction 14between two dissimilar metallic conductor leads 16 and 18. A proximalend 20 of each lead connects the thermocouple to appropriate hardwarefor use.

The junction between the two metals generates a voltage which is afunction of its temperature and the type of metals employed. Thetemperature at the junction can be determined by measuring the voltagevia leads connected to appropriate hardware in reference to tabular dataor by using various algorithms describing a given thermocouple'sperformance. While most thermocouple types are appropriate for use inthe present invention, T, J or K-type devices may be preferred becauseof their common nature and/or relative stability in temperaturemeasurement. Of course, the construction and operation of thermocouplesis well-known in the art.

Another sort of temperature sensor that may be employed in the presentinvention is commonly known as a thermistor. A thermistor is asemiconductor device that senses and detects temperature by measuringelectrical resistance. The silicon material of which a thermistor istypically made has a resistance that varies with temperature due to thesemiconductor material's high temperature coefficient of resistance.FIG. 1C shows a disk-shaped thermistor 22 that may be used in thepresent invention. Ends 20 of leads 16 and 18 connect the thermistor toappropriate hardware for use. The fabrication and operation ofthermistors is also well known in the art.

Still other types and/or formats of temperature sensor members may beemployed. For instance, junction-based thermal sensors (e.g., diode ortransistor temperature sensors), thermopile, fiber optic detectors,acoustic temperature sensors, quarts and other resonant temperaturesensors, thermo-mechanical temperature sensors or thin film resistiveelements may also be used. Detailed discussion of many of these devicesis presented in the “Micromachined Transducers Sourcebook,” by GregoryT. A. Kovacs, published by McGraw-Hill 1998. Other information regardingthe sensors is well known in the art.

With respect to any of the temperature sensors (those named and othersknown in the art), any of their common configurations may be employedeven though only certain examples are illustrated in the figures. Forexample, though FIG. 1C shows a disk-shaped thermistor 22, othersuitable common thermistor configurations include ceramic beads, chips,rods, washers, glass encapsulated beads, etc.

Based on the type(s) of temperature sensor selected, certain collateralhardware may be required. While colorimetric temperature sensors areself-contained and can be read without the aid of equipment, the samemay not true for all other types. One with skill in the art will easilyappreciate what sort of equipment need be connected or coupled to thetemperature sensors for taking measurements or detecting a temperaturedifference between at least two sensors. Further, the manner in whichelectronic memory may be coupled to store or record data taken to assistin diagnosis will be readily apparent.

Regarding such hardware that may be provided in connection withtemperature sensors (or impedance sensors as discussed above), it may beprovided in stand-alone system or monitor that the sensors (or a busswhich the sensors are connected to) mate with. Alternately, some or allof the hardware may be packaged with the sensors and the supportstructure selected. Another possibility is that a portion of thehardware that is used for data acquisition or interpretation is packagedwith the sensors and the remainder resides at a stand-alone location.Either a physical connection or remote/telemetry type connection may beemployed in this regard which the present invention is connected todirectly or via some form of remote connection.

RF signals sent and received by first and second telemetry units,respectively may be employed. An exemplary system applicable to such useis disclosed in U.S. Pat. No. 6,083,174 to Brehmeier-Flick. Othertelemetry units and applications thereof well known in the art are alsoapplicable to the present invention.

Regardless, transmission of data to other diagnostic and/or data storagedevice(s) may be carried out in burst or continuous fashion as describedvariously. Telemetry for use in the home is contemplated. In the case ofa hospitalized patient, telemetry of data to a central Intensive CareUnit (ICU) station provides another example of use.

In some variations of the invention, it will be preferred to include astorage device attached to sensors directly to store data indefinitely.Such an approach makes for a self-contained device that can beperiodically interfaced with a diagnostic instrument.

Regardless of the configuration, data storage may advantageously be usedin connection with the sensor chosen in a variety of ways. For instancedevelopment or resolution of an impedance profile, stored over time,between at least a first and second sensor members can signify abiological state of interest. Examples of such states include thedevelopment or resolution of absence of fluid or air collection, and theprogress of tissue swelling (immunologic proliferation), together withrelated physiological changes. Further, storage of impedance data canfacilitate comparison of the measurements taken against a look-up tableor database to assist in diagnosis.

Still, an impedance profile generated between at least a first and asecond sensor member locations, at a particular instant, may signify abiological state of interest. Examples of such states include: 1) thepresence or absence of fluid as in a hematoma, inflammatory mass,abscess or infection; 2) the presence or absence of air as in apneumothorax; or 3) the presence of a foreign body in tissue.

A number of useful observations can be made with respect to storedtemperature data as well. Both the development and/or resolution ofinfection can be monitored (even deep to the skin) through observationof stored sensor data. Additionally, the normal (uninfected) healing ofa wound may be observed. Just as infection results in increasedtemperature of tissue, so does the healing process, though generally toa lesser degree.

As normal wound healing progresses, wound temperature decreases tobaseline after about 72 hours. Accordingly, by observing a return tonormal temperature, an indication of completed wound healing isavailable. Conversely, an observation of continued elevation intemperature after 72 hours indicates the presence of an infection. Wherewound infection occurs, the temperature remains elevated or climbs,usually over that of normal (i.e., uninfected) tissues.

Other indications that may be observed through detection of developmentor resolution of a temperature difference, over time, between at least afirst and second include monitoring a diagnostic injection site forsigns of immunological proliferation or reactivity such as a TB tinetest and monitoring the state of a chronically inflamed tissue,including rheumatoid inflation or other chronic autoimmune disease.Where temperature is measured over a period of time, indication of abiological state may be derived from temperature measurement parameterssuch as temperature difference, or average temperature over a period oftime. As with monitors using impedance to observe biological states,temperature data obtained over a period of time may be compared to alook-up table or database. The use of such “categorized” data may be ofgreat assistance in drawing conclusions based on the data obtained.

Still further temperature-based methods according to the presentinvention involve determining pathological state of in view of thepresence or absence of a temperature difference between tissue regions,at a particular instant. Examples of such indications that may bedetected in this manner include: 1) vascular compromise to a tissueafter trauma or in occlusive vascular disease; 2) vascular compromise toa surgically modified tissue such as an AV fistula for dialysis, or areconstructive muscular flap procedure or other procedure requiringvascular anastomosis, or organ or tissue transplant; 3) detecting theboundary of viable tissue after an insult such as after a severe burn orfrostbite, or after infection with tissue destroying organisms such asclostridium perfringes; 4) in intraoperative monitoring of tissue wheredirect application of energy may impart excessive damaging heat such asduring phacoemulsification of the lens of the eye, or tympanoplasty ofinner ear, or during procedures involving eletrocautery orelectrocoagulation, or during procedures involving the administration ofheated agents such as high temperature chemotherapy, or thermal ablationof tumors; 5) likewise, in intraoperative monitoring of tissue wheredirect cooling may impart excessive damage to surrounding tissue such ascryoablation of tumor; 6) in monitoring of tissue during procedures fordiagnosis or therapy such as intraoperative cardiac perfusion monitoringor thermal dilution methods 7) in monitoring the state of localanesthesia due to the administration of anesthetic agents, or in thecondition of sympathetic nerve block, or autonomic dysfunction, and 8)immunological rejection of organ transplants. For such indications, atemperature-based diagnosis may be achieved by observation of atemperature rises/fall past a predefined limit once or observation of atemperature rises/fall past a predefined limit for a predeterminedperiod of time. In addition, a diagnosis may be made from observation ofraised or lowered temperature at one sensor location relative to areference temperature sensor location.

It is noted that in instances where temperature and impedance aremonitored over time (especially as facilitated by- storage andprocessing of results) to make a diagnosis, that there may be no need toseek a remotely-located reference against which to compare woundtemperature or impedance measurements. However, especially withtemperature-based systems according to the present invention whereinstantaneous results are desired, a reference measurement as well as asite-specific measurement is taken.

One type of sensor that lends itself to at-a-glance data acquisition isa calorimetric temperature sensor 24. An example of such a temperaturesensor is shown in figure ID. Such colorimetric temperature sensors areknown.

The temperature sensor pictured includes a grid of temperature-sensitivechemical indicators 30 deposited on a heat transmissive backing 32. Thebreakdown of indicators and an associated legend (not shown) or printingon the indicator panel can be used to allow a user to properly read thetemperature based on the state of the indicator dots.

The indicators may be comprised of a layer of encapsulated cholestericliquid crystals, ortho-bromonitrobenzine, ortho-chloronitrobenzine ormaterials such as those described in U.S. Pat. No. 4,232,552 to Hof etal., although a variety of other materials may also be used. Preferably,the composition selected is such that upward and downward fluctuationsin temperature are registered in an instantaneous or near-instantaneousmanner in order to facilitate repeatedly checking the temperature of asite.

FIG. 2A-2G show the various types of support members mentioned above,with optional sensor member placement locations indicated by arrows. Ineach of them, at least two sensor locations are shown.

With impedance sensors, where two sensor locations are provided, eachlocation corresponds to the end of an electrical lead 4. In such case,only one set of data (at a particular frequency) is generated. Withtemperature sensors, where two sensor locations are provided, separateor distinct temperature readings are provided at each location to givecomparative temperature readings.

Of course, as illustrated in the figures, more that two temperaturesensors may be provided. Likewise, several impedance sensors may beemployed, instead of just one having a pair of spaced-apart probes.

Hardware configured to include at least two sensor locations isspecifically adapted to the methodology contemplated by the presentinvention and is therefore most preferred. Still, the methodologydescribed in connection with FIGS. 3-6 below may be carried outotherwise. For instance, it may be carried out with discrete sensorsthat are not carried by a single support structure.

As for what is preferred, however, FIG. 2A shows a bandage 34 withspaced-apart temperature sensor locations 36 and/or impedance sensorlocations 38. The bandage preferably includes adhesive sections 40 and apad or gauze area 42.

For use in monitoring temperature, one sensor region 36 is preferablycentered on the bandage in order to register wound temperature, whereasan adjacent sensor location 36 offers a baseline temperature. The pointswhere temperature readings are taken should be separated by such adistance that a baseline temperature reading from one sensor isunaffected or not substantially affected by the temperature of whatevertissue that the other sensor is positioned to monitor. Stated anotherway a first sensor is set in proximity to undisturbed normal biologicaltissue and at least a second sensor is mounted proximally to the firstsensor at the site of disturbed biological tissue, which was subject toa traumatic incision or other action producing the wound. Sensorseparations of at least 1 cm may be approximate in certain cases.

Yet, base-line temperature sensor(s) locations(s) should be set so thattemperature readings produced are properly comparable to the site to bemonitored. For example, when an external wound is to be monitoredaccording to the present invention, an adjacent patch of skin willproduce an appropriate baseline temperature for comparison—whereas aninternally taken temperature may not since it will not be exposed to thesame environmental conditions as the site of interest that may causetemperature fluctuations.

The distance between impedance sensor members will also vary from oneapplication to another. It may depend on the form-factor of thedevice(s) used or based on other factors. That is to say, sensor memberspacing will vary from case-to-case. Appropriate spacing may bedetermined by those with skill in the art in view of the particularissue faced.

For use in monitoring for sub-surface fluid accumulation, preferredsensor element locations may differ from those employed for temperaturesensors. To use an impedance sensor most effectively in monitoring awound, the portion of its probes or electrodes in electrical contactwith a patient should straddle at least a portion of the wound.Alternately, side-to-side, top-to-side, or top-to-bottom placement ofsensor members relative to a wound, limb or other structure to bemonitored may prove effective, depending on the circumstances.

It is contemplated that the bandage or any other support member as maybe used in the present invention can be configured to monitor bothtemperature and impedance. In which case, staggered or spaced-apartsensor locations may be employed. Alternately, it may sometimes befeasible to use a shared set of sensor locations.

FIG. 2B shows a simple strip 44 serving as a support member. The stripmay be a polymeric member or made of another material. It includesvarious sensor placement locations 36 and 38. Such a support device isoptionally retained by a patient through the use of tape 46 or adhesive48 applied to a the skin.

FIG. 2C shows a patch or plate 50 as may be used as a support member. Itmay comprise a cotton or synthetic or fabric, alternately it may be madeof foam, a flexible polymer or a corrosion resistant metal such astitanium. Generally, it is preferred to use support members that are notsubstantially thermally conductive. It may cover a larger area andinclude a grid or matrix of sensor locations 36/38. It may be affixed toa patient by tape, another fixative or otherwise. Further, it may beimplanted.

Instead of affixing or adhering a sensor support structure to a patient,it may be retained by a patient or subject otherwise. FIG. 2D shows asensor support sleeve or cuff 52. It too includes a plurality of sensorlocations 36/38, placed as may be suitable for detecting the temperatureat one or more monitoring sites and one or more reference locations orimpedance at one or more sites. Such sensing may be at opposite sides ofthe sleeve. A sleeve can be expanded to fit over a digit or appendageand remain situated by elastic material incorporated into a portion ofthe sleeve or the entire device.

Yet another approach for a sensor support to be worn by a user ispresented by the use of a wrap 54 as shown in FIG. 2E. Sensors locations36/38 are shown adjacent one end. However any sort of convenientplacement may be selected. Elastic wraps or wraps made of non-elasticmaterial may be employed.

Still further, a bracelet 96 may be utilized as a support member. Asshown in FIG. 2H, the bracelet may include an adjustable interface 98.Various sensor location options are possible as with the other devicesdescribed herein.

Further possible support members include, suction cup member(s) 100/100′as shown in FIG. 2I. A singe suction cup may be employed, or a pluralityof associated members may be used. Any convenient means may be employedto associate at a desired distance or spacing such as a tie-bar 102 asshown. As to sensor location, in a single-cup type system, a pluralityof sensor members will be associated or embedded in the structure. Wherea multiple-cup system is provided, each may include as few as a singlesensor location 36/38.

Additional examples of possible sensor support structures also includeprosthetic members 104. FIG. 2J illustrates prosthetic knee components106. As in the preceding examples, sensor locations 36/38 may be locatedvariously.

FIG. 2F shows an example of a sensor support in the form of a shunt orgraft tube 56. Typically, a shunt is little more than a conduit attachedbetween two natural body fluid pathways to redirect flow or provideaccess to a given flow path. An exemplary shunt application ishemodialysis, usually between the radial artery and cephalic vein.Shunts find use in other applications as well, such as in communicatingblood from a patient's aorta to pulmonary artery as illustrated in FIG.5. A plurality of sensor locations are shown along the body of shunt 56.

FIG. 2G shows a drain or catheter 58. As with shunts, such devices maytake various forms. Drains are typically used to evacuate or establishan exit route for fluids or purulent material from any cavity or wound.Infusion catheters are often used to deliver drugs for thereby. An endsection of a perforated drain or catheter is shown. Orifices 60 conductfluid to or from a central lumen 62. Of course, other drain or catheterconfigurations may be used in the invention. Multiple-lumen designs arecommon. To infuse drugs or fluid irrigants, device 58 may be connectedto a pump. To assist in evacuation of fluid, the device may be connectedto suction. Either action is indicated by the double-arrow in FIG. 2G.

At a point upstream from the section shown in hatching, the drain orcatheter exits the body, through the wound itself that is beingmonitored or through remote stab incision. Temperature and or impedancesensors are preferably provided at locations 36/38 in the region of theimplanted portion of device 58 since sensors in this region will becapable of producing useful data.

Indeed, sensor members according to the present invention may beincorporated in any sort of implantable or semi-implantable device suchas those described above, variations of certain devices (e.g., thecatheter may be configured as a urinary and cardiac catheter), or otherimplant prosthesis devices. The manner in which implantable orsemi-implantable support structures according to the present inventionare retained by a patient may vary. A shunt may be secured using commontechniques such as suturing. The length of a drain is usually held inplace largely by virtue of its location, while its external portion issecured by suture(s) or tape to a patient's skin.

Both the drain or catheter and shunt advantageously include temperatureand impedance sensors. Combined ability to sense for infection and fluidvolume has particular applicability with these variations of the presentinvention. High incidents of infection are often associated withimplants, especially those with partial external exposure.

Actually, fluid-sensing capability of the present invention, whenemployed in shunts, grafts, infusion catheters and drains (and the like)offer the ability to monitor the efficacy/function of the devices.Accumulation of fluid (or the lack thereof) may indicate clogging,misplacement or another malfunction.

With implantable or semi-implantable variations of the invention, thesensors types included in FIGS. 1A-1C are preferred. Each of thesesensor types is readily monitored remotely by electronic means while thedevice is in situ.

It is contemplated that other types of electronic sensors may beincorporated in such devices as well (e.g., sensors able to detectbiochemicals associated with healing. Further, sensors as describedabove that are able to detect particular bacteria may be employed.

Whatever the type of sensor employed, it is contemplated that the mannerin which sensors are carried by any of the various sensor supportstructures disclosed may be varied. Where laminate constructions arepreferred, sensors may be located between layers. Of course, sensors maybe surface-mounted on the respective support structures. Other times,they will be set at their respective locations within the body of thesupport structure.

In instances where a layer of material is provided between a givensensor member or a portion of a sensor, this layer should be conductive.With respect to thermal or temperature sensors, the material should atleast be thermally conductive, rather than insulative. With respect toimpedance type sensors, the material should at least be electricallyconductive, such as conductive electrolyte gels, polymers or pastes orfabrics impregnated with such conductive or semi-conductive materials.

Particular hardware configurations for practicing methods according tothe present invention are shown in FIGS. 3-6. In FIG. 3, a patient'sforearm 64 is shown wearing an external monitor 66 according to thepresent invention over a wound 68. In this very basic variation of theinvention, a bandage 34 is affixed to the skin of a patient by adhesiveregions 40. First and second temperature locations 36 include (or arefilled by) colorimetric temperature sensors 24.

The temperature of the wound and the temperature of an adjacent locationis registered via the sensor patches 24 while monitor 66 is in place.Accurate temperature readings are obtained by thermal conductancethrough the sensor backing or any intermediate support layers. Bychecking the status of the sensors, the status of the wound may bedetermined.

When a sensor more amendable to electronic monitoring is used (such asthose in FIGS. 1A-1C), checking the status of a wound or another site ofinterest may be done automatically, including signaling values beyond adesired range. Such an approach may be easily implemented with hardwareand software as readily apparent to one with skill in the art.

FIG. 4 shows a bandage including spaced apart impedance sensormembers/leads/terminals 4 in connection with a patient's arm 64. Ends 10of each impedance sensor member are set at locations 38 straddling wound68.

With impedance sensing (preferably on either side of the wound), byusing various data processing techniques, the status, including locationof a region of fluid accumulation 70 beneath the skin can be detected.Such processing may be accomplished by hardware (and any associatedsoftware or logic) which the sensor leads are connected to. Alternately,certain hardware may be provided by on-board hardware 72 carried by thesensor support member. The same is true in situations where temperaturesensors are employed or where both temperature sensors and impedancesensors are employed.

Any such on-board hardware may include power supplies, memory, microchipprocessors and/or telemetry units. Memory may be used to record data forlater analysis and/or store programming to run included hardware. Atelemetry section of the on-board hardware may be included to avoid theneed to make a physical connection with external hardware to obtain orretrieve data

FIG. 5 shows another monitor employing self-contained hardware. Here ashunt 56 is shown attached between a patient's aorta 74 and pulmonaryvein 76. Impedance sensors probes 10 are provided at spaced apartlocations 38 along the device to monitor the surrounding area to give anindication whether the device it remains open and situated to properlypass blood between the anatomical structures.

A hardware support packet 78, including circuitry for measuringimpedance, a telemetry unit and such other features as desirable isprovided in the variation of the invention shown in FIG. 5. It isprovided separate from the shunt, but connected via electrical leads 80.The location of the hardware may be remote from the sensors, yet fullyimplanted to minimize issues associated with infection. By implanting itnear the surface of the skin, a counterpart unit 82 may be readilyemployed with inductive interface to recharge packet 78. Implanting sucha packet near the skin 84 of a patient or subject's body also reducesthe power requirements of telemetry units used to transmit data acquiredby the monitor to external hardware.

FIG. 6 illustrates the use of another type of monitor and methodologyaccording to the present invention. Again a patient's forearm 64 isshown in connection with a wound 68. A drain or catheter 58 is insertedthrough a stab 86 in the arm to release or evacuate fluid 70 from acavity 88 below the wound entry. Alternately, access to the cavity 88may be had through the wound incision.

The drain includes both temperature and impedance sensors located atintervals along the body of the device. Thermisors or thermocouples areequally preferred for use as the temperature sensors. Lead wires 80 fromthe sensors are preferably included in the device body 90 for connectionto support hardware. This preferred relation is shown magnified at asection taken in the device.

Such lead wires interface with hardware that preferably regularlymonitors the temperature status and/or impedance provided by thesensors. Certain programming to sound an alert or take remedial actionsuch as to increase or adjust suction from a drain, prompt adjustment ofthe shunt or increase the rate of drug delivery from a catheter may beemployed in response to data taken from such monitors and othersaccording to the present invention.

In many instances, the programmed action for hardware in associationwith any of the monitors will be to make and display a diagnosis basedon sensor results. The type or nature of any such diagnosis and/ordisplay may be of the sort referenced herein, in any of the documentsincorporated by reference or otherwise. A monitor display 92 as shown inFIG. 5 (but optionally incorporated in other hardware) is preferablyprovided so that complex messages or instructions can be communicated toa user or a physician. Alternately, a simple indicator 94 such as alight emitting diode as included in the hardware in FIG. 4 may beprovided to light up or change color to indicate a condition relating tosensor results. Hardware to sound an audio alarm or provide audioinstructions to a user of a monitor according to the present inventionmay also be provided.

In addition to (or instead of) providing alarms or user instructions,the monitors may be programmed and include such hardware or beinterfaced with such equipment as to allow it to direct remedial action.That is to say, monitors according to the present invention may activatesecondary devices to perform therapy such as deliver therapeuticmedications after triggered by an impedance change or profile or atemperature change or profile.

It is contemplated that various features of each of the embodimentsshown may be used with another. Furthermore, methodology most preferablycarried out with the variations of the invention disclosed may becarried out otherwise. For example it is contemplated that temperaturesensors used to make comparative temperature readings need notbe-carried by or be integral with a single support member. Especiallyfor variations of the invention taking internal temperature readings,obtaining a reference temperature at an area far remote from an area tobe monitored or studied may even be preferred. Still, including multipletemperature sensors along the length or surface of an internal monitoraccording to the present invention can provide advantages in terms ofpinpointing infection or inflammation such as in transplant rejection orautoimmune diseases such a rheumatoid arthritis in relation to anyportion of the device.

Further, as noted above, methods according to the present inventionusing repeated temperature sensing are not limited to monitoring woundsbut also include monitoring the state of locally anesthetized tissue,blood flow to muscle flaps or skin, tissue affected by burns, frostbiteor immunologic rejection of organ transplants. The status of eachindication is linked to blood flow and, hence, the temperature which thetissue will present at. With respect to producing systems for monitoringany of the latter indications that may recede or advance, a number ofindividual temperature sensors may be aligned in a series, grid ormatrix as shown in connection with the sensor support in FIG. 2C toallow tracking of the situation.

In addition, the present invention is applicable to situations where thepatient to be monitored is a viable fetus. For example, a monitor may beaffixed to or retained by a subject of fetal surgery. Also, monitoring(especially impedance-based monitoring) may be used to guard againsthydronephrosis, involving fluid accumulation and pressure build-up onthe kidney or interuterine conditions such as oligohydramnios orpolyhydramnios.

Additional potential applications of aspects of the presentinvention—and background regarding those mentioned above—are describedin connection with the following writings: Stein, L. E., et al., Acomparison of steady state and transient thermography techniques using ahealing tendon model Veterinary Surgery, 1988. 17(2): p. 90-6.; Horzic,M., K. Maric, and D. Bunoza, The temperature dynamics during the healingprocessing of a surgical wound. Biomed Tech (Berl), 1995. 40(4): p.106-9.; Viitanen, S. M. and J. Viljanto, Wound healing. A thermographicstudy. Annales Chirurgiae et Gynaecologiae Fenniae, 1972. 61(2): p.101-6.; Kiot, D. A. and S. J. Bimbaumn, Thermographic studies of woundhealing. American Journal of Obstetrics & Gynecology, 1965. 93(4): p.515-21.; Horzic, M., D. Bunoza, and K Maric, Three-dimensionalobservation of wound temperature inprimary healing. Ostomy Wound Manage,1996. 42(8): p. 38-40, 42-4, 46-7.; Horzic, M., D. Bunoza, and K. Maric,Contact Thermography in a study of primary healing of surgical wounds.Ostomy Wound Management, 1996. 42(1): p. 36-8.; Waterman, N. G., L.Goldberg, and T. Appel, Tissue temperatures in localized pyogenicinfections. American Journal of Surgery, 1969. 118(1): p. 31-5.;Golbranson, F. L., E. G. Yu, and R. H. Gelberman, The use of skintemperature determinations in lower extremity amputation levelselection. Foot & Ankle, 1982. 3(3): p. 170-2.; Stoner, H. B., L.Taylor, and R. W. Marcuson, The value of skin temperature measurementsin forecasting the healing of a below-knee amputation for end-stageischaemia of the leg in peripheral vascular disease. European Journal ofVascular Surgery, 1989. 3(4): p. 355-61.; Sandier, D. A. and J. F.Martin, Liquid crystal thermography as a screening test for deep-veinthrombosis. Lancet, 1985. 1(8430): p. 665-7.; Gaiziunas, A. G. and M. H.Hast, Temperature gradients and prediction off lap viability. Journal ofOtolaryrgology, 1976. 5(5): p. 399-402.; Holnstroom, H., Temperaturechanges of woundfluid inbipedicle tubeflaps. An experimental study.Scandinavian Journal of Plastic & Reconstructive Surgery, 1973. 7(2): p.102-4.; Hackett, M. E., The use of thermography in the assessment ofdepth of burn and blood supply of flaps, with preliminary reports on itsuse in Dupuytren's contracture and treatment of varicose ulcers. Br J.Plast Surg, 1974. 27(4): p. 311-7.; Frank, S. M., et al., Temperaturemonitoring practices during regional anesthesia [see commenis].Anesthesia & Analgesia, 1999. 88(2): p. 373-7.; Park, E. S., et al.,Comparison of sympathetic skin response and digital infraredthtermographic imaging in peripheral neuropathy. Yonsei Medical Journal,1994. 35(4): p. 429-37.; Palmer, J. B., et al., A cellist with arm pain:thermal asymmetry in scalenus anticus syndrome. Archives of PhysicalMedicine & Rehabilitation, 1991. 72(3): p. 237-42.; Pogrel, M. A., C.McNeill, and J. M. Kim, The assessment of trapezius muscle symptoms ofpatients with temporomandibular disorders by the use of liquid crystalthermography. Oral Surgery, Oral Medicine, Oral Pathology, OralRadiology, & Endodontics, 1996. 82(2): p. 145-51.; Robiesek, F., et al.,The application of thermography in the study of coronary blood flow.Collected Works on Cardiopulmonary Disease, 1979. 22: p. 49-56.;Robicsek, F., et al., The value of thermography in the early diagnosisof postoperative sternal wound infections. Thoracic & CardiovascularSurgeon, 1984. 32(4): p. 260-5.; Saxena, A. K, et al., Thermography ofClostridium perfringens infection in childhood. Pediatric SurgeryInternational, 1999. 15(1): p. 75-6.; Cole, R. P., et al., Thermographicassessment of burns using a nonpermeable membrane as wound covering.Burns, 1991. 17(2): p. 117-22.; Ferguson, J. C. and C. J. Martin, Astudy of skin temperatures, sweat rate and heat loss for burnedpatients. Clinical Physics & Physiological Measurement, 1991. 12(4): p.367-75.; Boylan, A., C. J. Martin, and G. G. Gardner, Infraredemissivity of burn wounds. Clinical Physics & Physiological Measurement,1992. 13(2): p. 125-7.; Wyllie, F. J. and A. B. Sutherland, Measurementof surface temperature as an aid to the diagnosis of burn depth. Burns,1991. 17(2): p. 123-7.; Mladick, R., N. Georgiade, and F. Thome, Aclinical evaluation of the use of thermography in determining degree ofburn injury. Plastic & Reconstructive Surgery, 1966. 38(6): p. 512-8.;Lawson, R. W., G. Webster, D., Thermographic Assessment of Burns andFrostbite. Can. Med. Ass. J., 1961. 84: p. 1129.; Yamagami, S. and H.Yamagami, Direct measurement of wound temperature duringphacoemulsification. Ophthalmologica, 1998. 212(1): p. 50-2.; Yamarnoto,K. and S. Osako, Temperature and humidity in the surgical wound cavityfollowing tympanaplasty. Jibiinkoka, 1966. 38(11): p. 1165-9.

For many variations of the invention, at least a portion of theinventive monitor is disposable or intended for one-time use. Instead ofattempting sterilization, discarding such portions of the inventioncoming into contact with a patient may in many cases be preferred or theonly reasonable option.

It is to be understood that the invention is not limited to the usesnoted above or by way of the exemplary description provided herein. Thebreadth of the present invention is to be limited only by the literal orequitable scope of the following claims. In construing the claims, any“support member” recited shall not be construed according to 35 U.S.C. §112, ¶6. Only when referred to as a “means for sensor support” shallcoverage under § 112, ¶6 be invoked for the sensor support structuresdisclosed. Likewise, only when the temperature and impedance sensorsdisclosed are referred to as a “means for sensing” are they (alone or incombination) to fall under § 112, ¶6.

1.-38. (canceled)
 39. A device for monitoring a condition of a subject,said device comprising: a support member; and one or more sensingportions supported by said support member, wherein said one or moresensing portions comprise at least one of: an impedance sensor and twotemperature sensors, wherein at least a portion of said device isadapted to be implantable in the body of said subject.
 40. The device ofclaim 39, further comprising electronic hardware connected to said oneor more sensing portions.
 41. The device of claim 40, wherein saidelectronic hardware includes one or more of an indicator forcommunicating information based on data from said one or more sensingportions; a telemetry or transmission unit; a memory unit; hardware fordata acquisition from said one or more sensing portions; and a powersource for said one or more sensing portions.
 42. The device of claim39, further comprising a programmed processor.
 43. The device of claim42, wherein said programmed processor is adapted to effect storage ofdata from said one or more sensing portions; to effect analysis of datafrom said one or more sensing portions; to effect a secondary medicalprocedure based on data from said one or more sensing portions; or toproduce a notification signal based on data from said one or moresensing portions.
 44. The device of claim 39, wherein said supportmember is tubular.
 45. The device of claim 39, wherein said supportmember is a shunt, a graft, a drain, a prosthesis or a catheter.
 46. Thedevice of claim 39, wherein the entire support member is adapted to beimplantable in the body of said subject.
 47. The device of claim 39,wherein said one or more sensing portions comprise two temperaturesensors.
 48. The device of claim 47, wherein said two temperaturesensors are spaced-apart a distance on said support member sufficient toobtain measurements of a wound comprising area using one of thetemperature sensors and measurements of an adjacent non-wound-comprisingarea of said subject using another temperature sensor.
 49. The device ofclaim 39, wherein said one or more sensing portions comprise animpedance sensor.
 50. The device of claim 49, wherein said impedancesensor is supported by said support in a manner sufficient to position aportion of said impedance sensor adjacent a first side of a wound ofsaid subject and a different portion of said impedance sensor adjacent asecond side of said wound.
 51. The device of claim 39, wherein said oneor more sensing portions comprise an impedance sensor and twotemperature sensors.
 52. A device for monitoring a condition of asubject, said device comprising: a user-retainable support membercomprising a sensor-supporting adhesive region and a sensor-supportingnon-adhesive region, one or more sensing portions supported by saidsensor-supporting adhesive region and one or more sensing portionssupported by said sensor-supporting non-adhesive region, wherein saidone or more sensing portions comprise at least one of: a portion of animpedance sensor and a temperature sensor.
 53. The device of claim 52,wherein said user-retainable support is a patch, bandage, strip, wrap,sleeve or bracelet.
 54. The device of claim 52, wherein said one or moresensing portions of said adhesive region comprise a first temperaturesensor and said one or more sensing portion of said non-adhesive regioncomprise a second temperature sensor.
 55. The device of claim 54,wherein said first and second temperature sensors are spaced-apart adistance on said user-retainable support member sufficient to obtainmeasurements of a wound-comprising area using one said first temperaturesensor and measurements of an adjacent non-wound-comprising area of saidsubject using said second temperature sensor.
 56. The device of claim52, wherein said one or more sensing portion of said adhesive regioncomprises a first electrode of an impedance sensor and said sensingportion of said non-adhesive region comprises a second electrode of saidimpedance sensor.
 57. The device of claim 52, further comprisingelectronic hardware connected to said one or more sensing portions. 58.The device of claim 57, wherein said electronic hardware includes one ormore of an indicator for communicating information based on data fromsaid one or more sensing portions; a telemetry or transmission unit; amemory unit; and hardware for data acquisition from said one or moresensing portions.
 59. The device of claim 52, further comprising aprogrammed processor.
 60. The device of claim 59, wherein saidprogrammed processor is adapted to effect storage of data from said oneor more sensing portions; to effect analysis of data from said one ormore sensing portions; to effect a secondary medical procedure based ondata from said one or more sensing portions; or to produce anotification signal based on data from said one or more sensingportions.
 61. A device for monitoring a condition of a subject, saiddevice comprising: a user-retainable support member comprising anon-adhesive region positioned between a first adhesive region and asecond adhesive region; and at least one sensor supported by said userretainable support member, wherein at least a part of said sensor ispositioned at said first adhesive region and at least a part of saidsensor is positioned at said second adhesive region.
 62. The device ofclaim 61, wherein said sensor comprises a first electrode and a secondelectrode and said first electrode is positioned at said first adhesiveregion and said second electrode is positioned at said second adhesiveregion.
 63. A system for monitoring a condition of a subject, saidsystem comprising first and second sensing structures, wherein eachsensing structure comprises a support member and one or more sensingportions supported by said support member, wherein said one or moresensing portions comprise at least one of: an impedance sensor and twotemperature sensors.
 64. The system of claim 63, wherein said one ormore sensing portions of said first sensing structure comprises a firsttemperature sensor and said one or more sensing portions of said secondsensing structure comprises a second temperature sensor.
 65. The systemof claim 63, wherein said first temperature sensor is capable ofobtaining the internal body temperature from a non wound-comprisingreference area of a subject and said second temperature sensor iscapable of obtaining the temperature of a wound-comprising area of saidsubject.
 66. The system of claim 63, further comprising electronichardware connected to said one or more sensing portions.
 67. The systemof claim 66, wherein said electronic hardware includes one or more of anindicator for communicating information based on data from said firstand second temperature sensors; a telemetry or transmission unit; amemory unit; hardware for data acquisition from said one or more sensingportions; and a power source for said one or more sensing portions. 68.The system of claim 63, further comprising a programmed processor. 69.The system of claim 68, wherein said programmed processor is adapted toeffect storage of data from said one or more sensing portions; to effectanalysis of data from said one or more sensing portions; to effect asecondary medical procedure based on data from said one or more sensingportions; or to produce a notification signal based on data from saidone or more sensing portions.